Write-up:Information has been received from Sanofi Pasteur MSD (MFR control number IE-1577272925-2016005356) on 23-MAY-2016. This case was received from RA (Ref no. IE-HPRA-2016-026661) on 18-MAY-2016. Initial case received from a consumer/other non-health professional concerns a 14-year-old female adolescent patient received GARDASIL (batch number unknown) on 03-JUN-2009, GARDASIL (batch number unknown) via intramuscular route on 13-AUG-2009 and 22-DEC-2009. The patient was not receiving any concomitant medications. The patient''s medical history/concurrent conditions were not reported. The patient experienced nausea, headaches, fatigue, muscle weakness, fainting, difficulty breathing, confusion, dizziness, joint pain, aching muscles, generally feeling unwell (for years after injection), memory loss, depression, anxiety, nightmares, agitated, sleep paralysis and difficulty to concentrate in September 2009/3 months post injection. The patient reported that she has received various psychiatric medications for years to treat the reactions. The patient is also receiving inhalers for breathing difficulties which she did not need prior to vaccination with GARDASIL. The patient is also attending a rheumatologist and a physiotherapist for an unspecified bone/muscle condition. The reporter assessed the causal relationship: between Nausea, Headache, Fatigue, Muscle weakness, Fainting, Difficulty breathing, Confusion, Dizziness, Joint pain, Muscle ache, Generally unwell, Memory loss, Depression, Anxiety, Nightmares, Agitated, Sleep paralysis, Concentration ability impaired and GARDASIL as Unknown. The patient reported that she cannot do ''normal'' things that other 21 year old girls can do due to the reactions experienced. The patient had a passion for every aspect of dancing and use to enter competitions regularly, but the patient had to stop after all this came on as her bones and muscles were too sore and she was ''way to tired'' to continue. The patient feels that she has very little quality of life compared with other people of her age. The patient''s outcome was reported as Not Recovered/Not Resolved.

Write-up:Information has been received from Sanofi Pasteur MSD (MFR control number IE-1577272925-2016005356) on 23-MAY-2016. This case was received from RA (Ref no. IE-HPRA-2016-026661) on 18-MAY-2016. Initial case received from a consumer/other non-health professional concerns a 14-year-old female adolescent patient received GARDASIL (batch number unknown) on 03-JUN-2009, GARDASIL (batch number unknown) via intramuscular route on 13-AUG-2009 and 22-DEC-2009. The patient was not receiving any concomitant medications. The patient''s medical history/concurrent conditions were not reported. The patient experienced nausea, headaches, fatigue, muscle weakness, fainting, difficulty breathing, confusion, dizziness, joint pain, aching muscles, generally feeling unwell (for years after injection), memory loss, depression, anxiety, nightmares, agitated, sleep paralysis and difficulty to concentrate in September 2009/3 months post injection. The patient reported that she has received various psychiatric medications for years to treat the reactions. The patient is also receiving inhalers for breathing difficulties which she did not need prior to vaccination with GARDASIL. The patient is also attending a rheumatologist and a physiotherapist for an unspecified bone/muscle condition. The reporter assessed the causal relationship: between Nausea, Headache, Fatigue, Muscle weakness, Fainting, Difficulty breathing, Confusion, Dizziness, Joint pain, Muscle ache, Generally unwell, Memory loss, Depression, Anxiety, Nightmares, Agitated, Sleep paralysis, Concentration ability impaired and GARDASIL as Unknown. The patient reported that she cannot do ''normal'' things that other 21 year old girls can do due to the reactions experienced. The patient had a passion for every aspect of dancing and use to enter competitions regularly, but the patient had to stop after all this came on as her bones and muscles were too sore and she was ''way to tired'' to continue. The patient feels that she has very little quality of life compared with other people of her age. The patient''s outcome was reported as Not Recovered/Not Resolved.